Watson Extraction System 14014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00197169140149), received between Apr 27, 2026 and Apr 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT CURVED LATERAL OSTEOTOME 14 AND STRAIGHT MEDIAL OSTEOTOME 14 WERE INVOLVED IN AN EVENT. DURING AN ATTEMPT TO REMOVE AN INFECTED FEMORAL STEM USING WATSON EXTRACTOR INSTRUMENTS, THE CONNECTION PART OF THE CURVED LATERAL OSTEOTOME 14 BLADE BROKE OFF AND BECAME LODGED IN THE FEMUR, REQUIRING ADDITIONAL TOOLS FOR REMOVAL. THE STRAIGHT MEDIAL OSTEOTOME 14 BLADE BENT AND WAS RENDERED UNUSABLE. THE STEM COULD NOT BE REMOVED WITH THE WATSON INSTRUMENTS, NECESSITATING AN EXTENDED TROCHANTERIC OSTEOTOMY (ETO) TO EXTRACT THE STEM, WHICH PROLONGED THE SURGICAL PROCEDURE. THERE WAS NO INDICATION THAT THE INSTRUMENT MALFUNCTIONS OR SURGICAL DELAYS RESULTED IN ANY DIRECT IMPACT TO THE SURGICAL OUTCOME OR CAUSED ANY PATIENT CONSEQUENCE OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25000721 ↗